Medical implant detachment systems and methods

ABSTRACT

An implant assembly comprises an elongated pusher member, and an implantable device (e.g., a vaso-occlusive device) mounted to the distal end of the pusher member. The implant assembly further comprises an electrolytically severable joint disposed on the pusher member, wherein the implantable device detaches from the pusher member when the severable joint is severed, and a return electrode carried by the distal end of the pusher member (e.g., a coil disposed about the pusher member) in proximity to, but electrically isolated from, the severable joint. The implant assembly further comprises a terminal carried by the proximal end of the pusher member in electrical communication with the severable joint.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of pending U.S. patentapplication Ser. No. 12/122,636, filed May 16, 2008, which claims thebenefit under 35 U.S.C. §119 of U.S. Provisional Patent Application Ser.No. 60/939,032, filed May 18, 2007. The foregoing applications are eachhereby incorporated by reference into the present application in theirentirety.

FIELD OF THE INVENTION

The invention relates generally to implantable devices (e.g., emboliccoils, stents, and filters) having flexible electrolytic detachmentmechanisms.

BACKGROUND

Implants may be placed in the human body for a wide variety of reasons.For example, stents are placed in a number of different anatomicallumens within the body. They may be placed in blood vessels to covervascular lesions or to provide patency to the vessels. Stents are alsoplaced in biliary ducts to prevent them from kinking or collapsing.Grafts may be used with stents to promote growth of endothelial tissuewithin those vessels. As another example, vena cava filters can beimplanted in the vena cava to catch thrombus sloughed off from othersites within the body and carried to the implantation site via the bloodstream.

As still another example, vaso-occlusive devices are used for a widevariety of reasons, including for the treatment of intravascularaneurysms. An aneurysm is a dilation of a blood vessel that poses a riskto health from the potential for rupture, clotting, or dissecting.Rupture of an aneurysm in the brain causes stroke, and rupture of ananeurysm in the abdomen causes shock. Cerebral aneurysms are usuallydetected in patients as the result of a seizure or hemorrhage and canresult in significant morbidity or mortality. Vaso-occlusive devices canbe placed within the vasculature of the human body, typically via acatheter, either to block the flow of blood through a vessel making upthat portion of the vasculature through the formation of an embolus orto form such an embolus within an aneurysm stemming from the vessel. Theembolus seals and fills the aneurysm, thereby preventing the weakenedwall of the aneurysm from being exposed to the pulsing blood pressure ofthe open vascular lumen.

One widely used vaso-occlusive device is a helical wire coil havingwindings, which may be dimensioned to engage the walls of the vessels.These coils typically take the form of soft and flexible coils havingdiameters in the range of 10-30 mils. Multiple coils will typically bedeployed within a single aneurysm. There are a variety of ways ofdischarging vaso-occlusive coils into the human vasculature. In additionto a variety of manners of mechanically deploying vaso-occlusive coilsinto the vasculature of a patient, U.S. Pat. No. 5,122,136, issued toGuglielmi et al., describes an electrolytically detachablevaso-occlusive coil that can be introduced through a microcatheter anddeployed at a selected location in the vasculature of a patient.

This vaso-occlusive coil is attached (e.g., via welding) to the distalend of an electrically conductive pusher wire. With the exception of asacrificial joint just proximal to the attached embolic device, theouter surface of the pusher wire is coated with an ionicallynon-conductive material. Thus, the sacrificial joint will be exposed tobodily fluids when deployed within the patient. A power supply is usedto provide power to the core wire, with a conductive patch orintravenous needle located on or in the patient providing a groundreturn path. Applying a positive voltage to the pusher wire via thepower supply relative to the ground return causes an electrochemicalreaction between the sacrificial joint and the surrounding bodily fluid(e.g., blood). As a result, the sacrificial joint will dissolve, therebydetaching the vaso-occlusive coil from the pusher wire at the selectedsite.

While the use of electrolytically detachable vaso-occlusive coils hasgenerally been successful, the period of time needed to detach thevaso-occlusive coils from the pusher wire is relatively long (currently,averaging from 30 to 40 seconds) and variable, resulting in an increasein procedure time. This problem is compounded by the need to deploymultiple vaso-occlusive coils within the patient. The relatively longand varying detachment time is due, in large part, to the relativelylarge and widely varying tissue impedance between the sacrificial jointand the ground electrode amongst patients. In addition, the bodily fluidsurrounding the sacrificial joint may not be the optimum electrolyte(compared with saline) for inducing an electrochemical reaction in thedetachment zone, thereby increasing the detachment time. Bloodenvironment may also introduce variability in detachment time due to thepossibility of blood clotting and the variations in blood constituentsamongst patients.

Theoretically, the voltage of the electrical energy supplied to thesacrificial joint can be increased in order to reduce the detachmenttime. However, an increased voltage may cause bubbling resulting fromgas generation byproducts during the electrochemical reaction, which mayinsulate the detachment zone adjacent the sacrificial joint from theelectrolyte, thereby slowing or stopping the electrochemical reaction,and at the least, causing variability in detachment time. In addition,because gas bubbles are more likely to be contained within the sheath ofthe microcatheter used to deliver the vaso-occlusive coil, deliverysystems are often designed, such that the sacrificial joint extends acertain distance (e.g., 1 mm) from the distal tip of the microcatheterto accommodate dimensional tolerance stackup in the pusher wire and themicrocatheter.

Exiting the microcatheter this far, however, degrades kickbackperformance (i.e., reaction of the microcatheter in response todetachment of the vaso-occlusive coil is to be minimized) due to thestiffness of the distal end of the pusher wire relative to the stiffnessof the vaso-occlusive coil. In addition, locating the sacrificial jointthis far from the distal tip of the microcatheter may cause it to comeinto contact with previously deployed vaso-occlusive coils, therebyshorting the sacrificial joint through the coils, resulting in anincrease and/or variation in the detachment time. Notwithstanding thebubbling issue, it may sometimes be difficult to ascertain that thesacrificial joint is in contact with the blood, which must occur toinitiate the electrochemical reaction and subsequent detachment of thevaso-occlusive coil.

SUMMARY OF THE INVENTION

In accordance with a one aspect of the present inventions, an implantassembly comprises an elongated pusher member, and an implantable device(e.g., a vaso-occlusive device) mounted to the distal end of the pushermember. The implant assembly further comprises an electrolyticallyseverable joint disposed on the pusher member, wherein the implantabledevice detaches from the pusher member when the severable joint issevered. The implant assembly further comprises a return electrodecarried by the distal end of the pusher member in proximity to, butelectrically isolated from, the severable joint. For example, the returnelectrode may take the form of a coil disposed about the pusher member.The return electrode may be carried by the pusher member in such amanner that it remains with the implantable device or remains the pushermember when the severable joint is severed. The implant assembly furthercomprises a terminal carried by the proximal end of the pusher member inelectrical communication with the severable joint. The use of a returnelectrode on the pusher member decreases the effective distance betweenthe anodic severable joint and cathodic return electrode, therebydecreasing the detachment time and increasing the reliability,repeatability, and uniformity of the detachment process.

In one embodiment, the implant assembly further comprises anotherterminal carried by the proximal end of the pusher member in electricalcommunication with the return electrode. In another embodiment, theterminal in electrical communication with the severable joint is theonly terminal carried by the proximal end of the pusher member. In anoptional embodiment, one or both of the severable joint and returnelectrode comprise silver chloride in order to facilitate anelectrolytic reaction between the severable joint and return electrode.For example, the severable joint and/or return electrode may comprise asilver core and a silver chloride coating. In another embodiment, thepusher member comprises an electrically conductive stiffening memberthrough which the terminal and the severable joint are in electricalcommunication.

In accordance with another aspect of the present inventions, a medicalsystem comprises an implant assembly that includes an elongated pushermember, an implantable device mounted to the distal end of the pushermember, an electrolytically severable joint disposed on the pushermember, wherein the implantable device detaches from the pusher memberwhen the severable joint is severed, and a return electrode carried bythe distal end of the pusher member in proximity to, but electricallyisolated from, the severable joint. The detailed features of the implantassembly can be similar to those described above. The medical systemfurther comprises an electrical power supply having a terminalelectrically coupled to the severable joint; for example, via a terminalcarried by the proximal end of the pusher member and/or an electricallyconductive stiffening member of the pusher member.

In some embodiments, the power supply has another terminal electricallycoupled to the return electrode (e.g., via another terminal carried bythe proximal end of the pusher member) or electrically coupled to aground electrode that is separate from the return electrode. In oneembodiment, the power supply is configured for delivering direct currentto the implant assembly. In another embodiment, the medical systemfurther comprises a delivery catheter configured for slidably receivingthe implant assembly.

In accordance with other aspect of the present inventions, a method ofimplanting a medical device (e.g., a vaso-occlusive device) within apatient is provided. The method comprises introducing the medical devicewithin the patient via a pusher member (e.g., through a deliverycatheter), conveying electrical energy (e.g., direct electrical current)to a joint disposed on the pusher member, and conveying electricalenergy from a return electrode carried by the pusher member (e.g., acoil disposed about the pusher member) to induce an electrolyticreaction between the joint and the return electrode. As a result of theelectrolytic reaction, the joint is severed to detach the medical devicefrom the pusher member at a target site (e.g., an aneurismal sac) withinthe patient. The return electrode may, e.g., remain with the medicaldevice when the joint is severed or remain with the pusher member whenthe joint is severed.

In one method, the electrolytic reaction comprises releasing chlorideions from the return electrode. The electrical energy may be conveyed tothe joint via the pusher member, and the electrical energy may beconveyed from the return electrode via the pusher member or from thereturn electrode to a ground electrode via the tissue of the patient. Inanother method, the pusher member is removed from the patient.

In accordance with another aspect of the present inventions, an implantassembly comprises an elongated pusher member that has a stiffeningmember and an electrically conductive sheath (e.g., a coil, mesh, orbraid) disposed over the stiffening member. The stiffening member may becomposed of a suitable material, such as stainless steel, and theelectrically conductive sheath may be composed of a suitable material,such as copper or silver. The implant assembly further comprises animplantable device (e.g., a vaso-occlusive device) mounted to the distalend of the pusher member. The implant assembly further comprises anelectrolytically severable joint disposed on the pusher member, whereinthe implantable device detaches from the pusher member when theseverable joint is severed. The implant assembly further comprises areturn electrode carried (e.g., mounted) by the distal end of the pushermember in proximity to, but electrically isolated from, the severablejoint. In one embodiment, the return electrode takes the form of a coildisposed about the pusher member. The return electrode may be carried bythe pusher member in such a manner that it remains with the implantabledevice or remains the pusher member when the severable joint is severed.

The implant assembly further comprises a terminal carried by theproximal end of the pusher member in electrical communication with theseverable joint. The implant assembly further comprises an electricallyconductive path extending between the terminal and one of the severablejoint and the return electrode, wherein the electrically conductive pathincludes the electrically conductive sheath. The use of the electricallyconductive sheath increases the conductance of the electricallyconductive path between the terminal and the severable joint or returnelectrode, as compared to the case where a standard electrical conductoror the stiffening member is used without the electrically conductivesheath.

In one embodiment, the electrically conductive path extends between theterminal and the return electrode, in which case, the electricallyconductive sheath and stiffening member are electrically isolated fromeach other. For example, the stiffening member may comprise anelectrically conductive core wire and an electrically insulative coatingdisposed over the core wire, wherein the electrically insulative sheathis disposed over the electrically insulative coating. In anotherembodiment, the stiffening member has a proximal section having a firstdiameter and a distal section having a second decreased diameter, inwhich case, the electrically conductive path only extends between theterminal and the severable joint along the distal section of thestiffening member.

In another embodiment, the implant assembly further comprises anotherterminal carried by the proximal end of the pusher member in electricalcommunication with the return electrode, and the pusher member includesanother electrically conductive sheath disposed over the stiffeningmember. In this case, the implant assembly may further comprise anotherelectrically conductive path extending between the other terminal andanother of the severable joint and the return electrode, such that theother electrically conductive path includes the other electricallyconductive sheath.

In accordance with a further aspect of the present inventions, anotherimplant assembly is provided. The implant assembly comprises anelongated pusher member, an implantable device mounted to the distal endof the pusher member, an electrolytically severable joint disposed onthe pusher member, a terminal carried by the proximal end of the pushermember, and the implant assembly further comprises an electricallyconductive path extending between the terminal and the severable joint,wherein the electrically conductive path includes the electricallyconductive sheath. The features of the implant assembly can be the sameas those described above.

In accordance with still another aspect of the present inventions, amedical system comprises either of the implant assemblies describedabove, and an electrical power supply having a terminal electricallycoupled to the terminal of the implant assembly. If a return electrodeis provided on the implant assembly, the medical system may beconfigured in one of two manners. In one example, the medical systemfurther comprises a ground electrode separate from the return electrode,in which case, the power supply has another terminal electricallycoupled to the ground electrode. In another example, the implantassembly has another terminal in electrical communication with thereturn electrode, in which case, the power supply has another terminalelectrically coupled to the other terminal of the implant assembly. Inan optional embodiment, the medical system further comprises a deliverycatheter configured for slidably receiving the implant assembly.

In accordance with still another aspect of the present inventions, animplant assembly comprises an elongated pusher member, and animplantable device (e.g., a vaso-occlusive device) mounted to the distalend of the pusher member. The implant assembly further comprises anelectrolytically severable joint disposed on the pusher member, whereinthe implantable device detaches from the pusher member when theseverable joint is severed. The implant assembly further comprises aterminal carried by the proximal end of the pusher member in electricalcommunication with the severable joint. In one embodiment, the pushermember comprises an electrically conductive stiffening member throughwhich the terminal and the severable joint are in electricalcommunication.

The implant assembly further comprises a return electrode carried by thedistal end of the pusher member. In one embodiment, the returnelectrodes takes the form of a coil disposed about the pusher member.The return electrode is electrically isolated from the severable jointand is configured to remain with the pusher member when the severablejoint is severed. Although the present inventions should not be solimited in their broadest aspects, the return electrode need not becomposed of more expensive and electrically limiting biocompatiblematerials suitable for chronic implantation, since the return electroderemains with the pusher member. In one embodiment, the implant assemblyfurther comprises another terminal carried by the proximal end of thepusher member in electrical communication with the return electrode. Inanother embodiment, the terminal in electrical communication with theseverable joint is the only terminal carried by the proximal end of thepusher member.

In accordance with yet another aspect of the present inventions, amedical system comprises an implant assembly that includes an elongatedpusher member, an implantable device mounted to the distal end of thepusher member, an electrolytically severable joint disposed on thepusher member, wherein the implantable device detaches from the pushermember when the severable joint is severed, and a return electrodecarried by the distal end of the pusher member. The detailed features ofthe implant assembly can be similar to those described above. Themedical system further comprises an electrical power supply having aterminal electrically coupled to the severable joint; for example, via aterminal carried by the proximal end of the pusher member and/or anelectrically conductive stiffening member of the pusher member.

In accordance with yet another aspect of the present inventions, amethod of implanting a medical device (e.g., a vaso-occlusive device)within a patient is provided. The method comprises introducing themedical device within the patient via a pusher member (e.g., through adelivery catheter), conveying electrical energy (e.g., direct electricalcurrent) to a joint disposed on the pusher member, and conveyingelectrical energy from a return electrode carried by the pusher member(e.g., a coil disposed about the pusher member) to induce anelectrolytic reaction between the joint and the return electrode. As aresult of the electrolytic reaction, the joint is severed to detach themedical device from the pusher member at a target site (e.g., ananeurismal sac) within the patient. The return electrode remains withthe pusher member when the joint is severed. The electrical energy maybe conveyed to the joint via the pusher member, and the electricalenergy may be conveyed from the return electrode via the pusher memberor from the return electrode to a ground electrode via the tissue of thepatient. In one method, the pusher member is removed from the patient.

In accordance with yet another aspect of the present inventions, animplant assembly comprises an elongated pusher member, and animplantable device (e.g., a vaso-occlusive device) mounted to the distalend of the pusher member. The implant assembly further comprises anelectrolytically severable joint disposed on the pusher member, whereinthe implantable device detaches from the pusher member when theseverable joint is severed. The implant assembly further comprises aterminal carried by the proximal end of the pusher member in electricalcommunication with the severable joint. In one embodiment, the pushermember comprises an electrically conductive stiffening member throughwhich the terminal and the severable joint are in electricalcommunication.

The implant assembly further comprises a return electrode carried by thedistal end of the pusher member, and electrically isolated from theseverable joint. The return electrode may be carried by the pushermember in such a manner that it remains with the implantable device orremains the pusher member when the severable joint is severed.

The implant assembly further comprises an electrically insulative sheath(e.g., one composed of a polymeric material) fixably coupled to thepusher member and circumferentially surrounding the severable joint andthe return electrode. In one embodiment, the return electrodecircumferentially extends around the severable joint, and the insulativesheath is disposed about the return electrode. In this case, the returnelectrode may be, e.g., a coil or a continuous cylinder. The implantassembly may comprise an electrically insulative spacer mounted to thedistal end of the pusher member to prevent contact between the severablejoint and the return electrode.

In one embodiment, the insulative sheath is configured to preventdiffusion of an electrolyte from a detachment region between theseverable joint and the return electrode. In this manner, theelectrically insulative sheath may maintain the ideal electrolyticenvironment within the detachment region between the severable joint andthe return electrode in order to facilitate detachment of the implantassembly. In one embodiment, one or both of the severable joint and thereturn electrode has a hydrophilic coating, so as to, e.g., facilitatewicking of an electrolyte within the detachment region when desired.

In accordance with yet another aspect of the present inventions, amedical system comprises an implant assembly that includes an elongatedpusher member, an implantable device mounted to the distal end of thepusher member, an electrolytically severable joint disposed on thepusher member, wherein the implantable device detaches from the pushermember when the severable joint is severed, a return electrode carriedby the distal end of the pusher member, and an electrically insulativesheath fixably coupled to the pusher member and circumferentiallysurrounding the severable joint and the return electrode. The detailedfeatures of the implant assembly can be similar to those described abovein other embodiments. The medical system further comprises an electricalpower supply having terminal electrically coupled to the severablejoint; for example, via a terminal carried by the proximal end of thepusher member and/or an electrically conductive stiffening member of thepusher member.

In accordance with still another aspect of the present inventions, amethod of implanting a medical device (e.g., a vaso-occlusive device)within a patient using a pusher member is provided. A joint is disposedon the pusher member and a return electrode is carried by the pushermember. The method comprises introducing an electrolyte within adetachment region between the joint and the return electrode. Forexample, the electrolyte may be wicked into the detachment region. Inone method, the electrolyte is introduced within the detachment regionbefore the medical device is introduced into the patient.

The method further comprises introducing the medical device within thepatient via a pusher member (e.g., through a delivery catheter), andsubstantially preventing the electrolyte from being diffused away fromthe detachment region using an electrically insulative sheath. In oneembodiment, the insulative sheath is fixably coupled to the pushermember. The method further comprises conveying electrical energy (e.g.,direct electrical current) to a joint disposed on the pusher member, andconveying electrical energy from a return electrode carried by thepusher member (e.g., a coil disposed about the pusher member) to inducean electrolytic reaction between the joint and the return electrode. Asa result of the electrolytic reaction, the joint is severed to detachthe medical device from the pusher member at a target site (e.g., ananeurismal sac) within the patient. In one method, the pusher member isremoved from the patient.

In accordance with yet another aspect of the present inventions, amedical system comprises an implant assembly that includes an elongatedpusher member, an implantable device (e.g., a vaso-occlusive device)mounted to the distal end of the pusher member, and an electrolyticallyseverable joint disposed on the pusher member, wherein the implantabledevice detaches from the pusher member when the severable joint issevered. The medical system further comprises an electrical power supplycoupled to the implant assembly, the power supply configured forconveying pulsed electrical energy (e.g., direct electrical current) tothe severable joint. By way of non-limiting example, the pulsedelectrical energy may have a duty cycle within the range of 5 percent to20 percent, and a frequency in the range of 5 KHz to 20 KHz. Pulsing theelectrical energy delivered to the severable joint will tend to decreasethe detachment time and increase the reliability, repeatability, anduniformity of the detachment process.

In one embodiment, the implant assembly further comprises a terminalcarried by the proximal end of the pusher member in electricalcommunication with the severable joint, wherein the terminal of thepower supply is electrically coupled to the terminal of the implantassembly. In another embodiment, the power supply has another terminalelectrically coupled to a return electrode, which may be carried by thepusher member. The terminals of the power supply have differentelectrical potentials.

In one embodiment, the power supply includes a constant current sourcefor conveying the electrical energy, e.g., at an amplitude within therange of 0.25 mA to 10 mA. In another embodiment, the power supplyincludes a constant voltage source for conveying the electrical energy,e.g., at an amplitude within the range of 0.5V to 11V. In an optionalembodiment, the power supply includes a constant current source, aconstant voltage source, and a controller configured for initiallyconveying the electrical energy from the constant current source, andsubsequently conveying the electrical energy from the constant voltagesource. In another embodiment, the medical system comprises a deliverycatheter configured for slidably receiving the implant assembly.

In accordance with a further aspect of the present inventions, a methodof implanting a medical device (e.g., a vaso-occlusive device) within apatient is provided. The method comprises introducing the medical devicewithin the patient via a pusher member (e.g., through a deliverycatheter), and conveying pulsed electrical energy (e.g., directelectrical current) to a joint disposed on the pusher member to inducean electrolytic reaction at the joint. By way of non-limiting example,the pulsed electrical energy may have a duty cycle within the range of 5percent to 20 percent, and a frequency in the range of 5 KHz to 20 KHz.As a result of the electrolytic reaction, the joint is severed to detachthe medical device from the pusher member at a target site (e.g., ananeurismal sac) within the patient.

In one method, the electrical energy is conveyed to the joint via thepusher member. An optional method comprises conveying pulsed electricalenergy from a return electrode (e.g., one carried by the pusher member)to induce the electrolytic reaction between the joint and the returnelectrode. In one method, the electrical energy is conveyed to the jointfrom a constant current source, e.g., one having an amplitude within therange of 0.25 mA to 10 mA. In another method, the electrical energy isconveyed to the joint from a voltage source, e.g., one having a voltagewithin the range of 0.5V to 11V. In an optional method, the pulsedelectrical energy is initially conveyed to the joint from a constantcurrent source, and subsequently conveyed to the joint from a constantvoltage source. In another method, the pusher member is removed from thepatient.

In accordance with still further aspects of the present inventions, amedical system is provided, which comprises an implant assembly thatincludes an elongated pusher member, an implantable device (e.g., avaso-occlusive device) mounted to the distal end of the pusher member,and an electrolytically severable joint disposed on the pusher member,wherein the implantable device detaches from the pusher member when theseverable joint is severed. The medical system further comprises anelectrical power supply coupled to the implant assembly. The powersupply includes a constant current source (e.g., one having an amplitudein the range of 0.25 mA to 10 mA), a constant voltage source (e.g., onehaving an amplitude in the range of 0.5V to 11V), and a controllerconfigured for conveying electrical energy from the constant currentsource to the severable joint (e.g., for a time period in the range of0.5 seconds to 1 second), and subsequently conveying electrical energyfrom the constant voltage source to the severable joint. The electricalenergy may be, e.g., direct electric current.

The initial electrical energy from the constant current source mayquickly break through the oxide layer on the severable joint, whereasthe electrical energy from the constant voltage source may minimizebubbling at the detachment region, thereby decreasing the detachmenttime and increasing the reliability, repeatability, and uniformity ofthe detachment process.

In one embodiment, the implant assembly further comprises a terminalcarried by the proximal end of the pusher member in electricalcommunication with the severable joint, wherein the terminal of thepower supply is electrically coupled to the terminal of the implantassembly. In another embodiment, the power supply has another terminalelectrically coupled to a return electrode, which may be carried by thepusher member. The terminals of the power supply have differentelectrical potentials. In another embodiment, the medical systemcomprises a delivery catheter configured for slidably receiving theimplant assembly.

In accordance with a yet another aspect of the present inventions, amethod of implanting a medical device (e.g., a vaso-occlusive device)within a patient is provided. The method comprises introducing themedical device within the patient via a pusher member (e.g., through adelivery catheter), conveying electrical energy from a constant currentsource to a joint disposed on the pusher member to degrade an oxidelayer on the joint, and subsequently conveying electrical energy from aconstant voltage source to the joint to induce an electrolytic reactionat the joint. The electrical energy may be, e.g., direct electricalcurrent. As a result of the electrolytic reaction, the joint is severedto detach the medical device from the pusher member at a target site(e.g., an aneurismal sac) within the patient.

In one method, the electrical energy is conveyed to the joint via thepusher member. An optional method comprises conveying electrical energyfrom a return electrode (e.g., one carried by the pusher member) toinduce the electrolytic reaction between the joint and the returnelectrode. In another method, the pusher member is removed from thepatient.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF DRAWINGS

The drawings illustrate the design and utility of preferredembodiment(s) of the invention, in which similar elements are referredto by common reference numerals. In order to better appreciate theadvantages and objects of the invention, reference should be made to theaccompanying drawings that illustrate the preferred embodiment(s). Thedrawings, however, depict the embodiment(s) of the invention, and shouldnot be taken as limiting its scope. With this caveat, the embodiment(s)of the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is a plan view of a medical system arranged in accordance withone embodiment of the present invention, wherein the medical systemparticularly delivers a vaso-occlusive device into a patient using abipolar electrolytic delivery means;

FIG. 2 is a plan view of a medical system arranged in accordance withanother embodiment of the present inventions, wherein the medical systemparticularly delivers a vaso-occlusive device into a patient using amonopolar electrolytic delivery means;

FIG. 3 is a block diagram of an optional power supply that can be usedin either of the medical systems of FIGS. 1 and 2;

FIG. 4 is a perspective view of one embodiment of a vaso-occlusivedevice that can be delivered in either of the medical systems of FIGS. 1and 2;

FIG. 5 is a cross-sectional view of one embodiment a bipolar implantassembly that can be used in the medical system of FIG. 1;

FIG. 6 is a cross-sectional view of one embodiment a monopolar implantassembly that can be used in the medical system of FIG. 2;

FIG. 7 is a cross-sectional view of another embodiment a bipolar implantassembly that can be used in the medical system of FIG. 1;

FIG. 8 is a cross-sectional view of another embodiment a monopolarimplant assembly that can be used in the medical system of FIG. 2;

FIG. 9 is a diagram illustrating relative voltage differences in amonopolar arrangements that utilizes an intermediate return electrode;

FIG. 10 is a cross-sectional view of another embodiment a bipolarimplant assembly that can be used in the medical system of FIG. 1;

FIG. 11 is a cross-sectional view of still another embodiment a bipolarimplant assembly that can be used in the medical system of FIG. 1;

FIG. 12 is a cross-sectional view of yet another embodiment a bipolarimplant assembly that can be used in the medical system of FIG. 1; and

FIGS. 13A-13C are cross-sectional views illustrating a method ofdelivering a vaso-occlusive device within an aneurysm of the patientutilizing the medical systems of FIG. 1 or FIG. 2.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Referring generally to FIGS. 1 and 2, a medical system 10 constructed inaccordance with one embodiment of the present inventions will bedescribed. The medical system 10 is used in vascular and neurovascularindications, and particularly in the treatment of aneurysms, such ascerebral aneurysms. The medical system 10 utilizes an electrolyticdetachment means to deploy vaso-occlusive devices, such as helicalcoils, within an aneurysm. Alternatively, the medical system 10 can beutilized to deploy implantable devices other than vaso-occlusivedevices. For example, the medical system 10 can alternatively be used todeploy stents and vena cava filters, which are described in furtherdetail in U.S. Pat. No. 6,468,266, which is expressly incorporatedherein by reference.

To this end, the medical system 10 generally comprises a deliverycatheter 12 that can be intravenously introduced within a patient toaccess a target site within the vasculature, an implant assembly 14 thatcan be slidably disposed within the delivery catheter 12, and anelectrical power supply 16 that can supply electrical energy to theimplant assembly 14 to effect the electrolytic detachment process.

Various types of implant assemblies 14 will be described herein, all ofwhich include a pusher member 18, an electrolytically severable joint20, and a detachable vaso-occlusive implant 22 mounted to the distal endof the pusher member 18. As will be described in further detail below,the vaso-occlusive implant 22 detaches from the pusher member 18 whenthe joint 20 is electrolytically severed.

Some of the implant assemblies 14 described herein use bipolarelectrolytic means to detach the vaso-occlusive implant 22 from thepusher member 18 at the severable joint 20, and others use monopolarelectrolytic means to detach the vaso-occlusive implant 22 from thepusher member 18 at the severable joint 20. In the bipolar cases (shownspecifically in FIG. 1), the implant assembly 14 includes positive andnegative terminals 28, 30 disposed on the proximal end 24 of the pushermember 18, and a return (ground) electrode (not shown in FIG. 1) carriedby the distal end 26 of the pusher member 18. The positive terminal 28is electrically coupled to the severable joint 20, whereas the negativeterminal 30 is electrically coupled to the return electrode. In themonopolar case (shown specifically in FIG. 2), the implant assembly 14includes a single terminal 28 disposed on the proximal end 24 of thepusher member 18. In this case, the system 10 includes a returnelectrode 32 in the form of a ground patch electrode or ground needleelectrode, and an optional intermediate return electrode (not shown inFIG. 2) carried by the distal end 26 of the pusher member 18. In eitherof the monopolar or bipolar arrangements, the severable joint 20 servesas an anode, and the return electrode or ground electrode serves as acathode.

Notably, because of the close proximity of the severable joint 20 andreturn electrode in the bipolar case, there is a greater chance that thereturn electrode will induce gas bubbling that will adversely effect thedetachment process. That is, greater volumes of bubbling at the returnelectrode that can displace electrolyte may be created, thus insulatingthe return path, and thereby causing a variable return electrodeimpedance (changing voltage drop at the severable joint 20). As will bedescribed in further detail below, the pusher member 18 can be providedwith various features that prevent or minimize such bubbling, so thatthe full advantages of a bipolar configuration can be achieved. Thesefeatures can likewise be used in the monopolar configuration as well toreduce the chance of gas bubbling.

The power supply 16 conveys electrical energy to the implant assembly 14(and in particular, the severable joint 20) and returns electricalenergy either from the implant assembly 14 (and in particular, thereturn electrode) or the ground electrode, to effect the electrolyticdetachment of the vaso-occlusive implant 22. To this end, the powersupply 16 has a positive terminal 34 configured to mate with thepositive terminal 28 of the implant assembly 14 via a cable 38, and anegative terminal 36 configured to mate with the negative terminal 30 ofthe implant assembly 14 (FIG. 1) or the ground electrode 32 (FIG. 2) viaa cable 40. Alternatively, in the case of a monopolar arrangement, thepositive terminal 24 of the implant assembly 14 is mated directly to thepositive terminal 34 of the power supply 16, and in the case of abipolar arrangement, the positive and negative terminals 28, 30 of theimplant assembly 14 are mated directly to the positive and negativeterminals 34, 36 (which may be configured in a front-to-backrelationship instead of the side-by-side relationship illustrated inFIG. 2) of the power supply 16. For the purposes of this specification,the terms “positive” and “negative” with respect to a terminal isrelative and merely means that the positive terminal has a greatervoltage potential than that of the negative terminal.

In a monopolar arrangement, the power supply 16 preferably includes aconstant current source (not shown in FIGS. 1 and 2) from which theelectrical energy is conveyed. In this manner, the detachment times arenot affected by the widely varying tissue impedances between theremotely positioned severable joint 20 and ground electrode 32 amongstdifferent patients. A suitable amplitude range for the constant currentsource is between 0.25 mA and 10 mA. The bipolar arrangement isparticularly advantageous, because the varying tissue impedance will notadversely affect the detachment time due to the close proximity betweenthe severable joint 20 and return electrode. As such, the power supply16 preferably includes a constant voltage source (not shown in FIGS. 1and 2), which results in a predictable return path voltage drop thatavoids over-driving the voltage at the severable joint 20 (anode), whichmay otherwise cause gas generation (i.e., bubbling). A suitableamplitude range for the constant voltage source is between 0.5V and 11V.

In either of the bipolar configuration or monopolar configuration, theelectrical energy takes the form of continuous direct electrical energy;that is, electrical energy that continually flows in one direction only.In an optional embodiment, the power supply 16 is configured to pulsethe direct electrical energy supplied by the constant current source orconstant voltage source. It has been discovered that pulsing theelectrical energy eliminates or minimizes bubbling at the detachmentzone. A suitable frequency range and duty cycle for pulsing theelectrical energy is 5 KHz to 20 KHz and 5% to 20%, respectively.

In an optional embodiment illustrated in FIG. 3, the power supply 16includes both of a constant current source 42 and a constant voltagesource 44 coupled to a radio frequency (RF) oscillator 46, and acontroller 48 for initially conveying the electrical energy from theconstant current source 42 and subsequently conveying the electricalenergy from the voltage current source 44; that is, by selectivelycoupling the constant current source 42 and constant voltage source 44to the positive terminal 34 via switch 50. This option works best in abipolar arrangement, wherein the electrical energy can be delivered fromthe constant current source 42 to quickly break through the oxide layeron the severable joint 20 for a certain time period (e.g., 0.5 s to 1.0s), and then the electrical energy can be delivered from the constantvoltage source 44 to minimize bubbling at the detachment zone.

Referring back to FIGS. 1 and 2, the delivery catheter 12 includes anelongate, flexible, tubular member 52 composed of a suitable polymericmaterial and optionally reinforced with a coil or braid to providestrength or obviate kinking propensities. The delivery catheter 12further includes a lumen (not shown) through which the implant assembly14 can be selectively located. The delivery catheter 12 further includesa pair of radiopaque markers 58 disposed on the distal end 54 of thetubular member 52 to allow visualization of the delivery catheter 12relative to the vaso-occlusive implant 22. The delivery catheter 12further includes a proximal fitting 60 disposed on the proximal end 56of the tubular member 52 for introduction of the implant assembly 14, aswell as for the optional introduction of dyes or treatment materials.

Referring to FIG. 4, the vaso-occlusive implant 22 is standard andcomprises a helically wound primary coil 62 having a proximal end 64, adistal end 66, and a lumen 68 extending therethrough. The materials usedin constructing the primary coil 62 may be any of a wide variety ofmaterials, and preferably, a radio-opaque material such as a metal or apolymer. Suitable metals and alloys for the wire making up the coilinclude super-elastic alloy, such as titanium/nickel alloy, known as“nitinol”, or include Platinum Group metals, especially platinum,rhodium, palladium, rhenium, as well as tungsten, gold, silver,tantalum, and alloys of these metals. In addition to being largelybiologically inert, these metals have significant radio-opacity andtheir alloys may be tailored to accomplish an appropriate blend offlexibility and stiffness. Highly preferred is a platinum/tungstenalloy, e.g., 8% tungsten and the remainder platinum.

The primary coil 62 may also be made of radiolucent fibers or polymers(or metallic threads coated with radiolucent or radio-opaque fibers)such as Dacron (polyester), polyglycolic acid, polylactic acid,fluoropolymers (polytetrafluoroethylene), Nylon (polyamide), or evencotton or silk. If a polymer is used as the major component of theprimary coil 62, it is desirably filled with some amount of radio-opaquematerial, such as powdered tantalum, powdered tungsten, bismuth oxide,barium sulfate, and the like.

The primary coil 62 may generally be composed of a wire having adiameter in the range of 0.0025 inches to 0.006 inches, which is thenwound into a primary form having a diameter between 0.003 inches and0.025 inches. But for most neurovascular applications, a diameterbetween 0.008 to 0.018 inches provides sufficient hoop strength to holdthe primary coil 62 in place within the chosen body site, lumen, orcavity, without substantially distending the wall of the site andwithout moving from the site as a result of the repetitive fluid pulsingfound in the vascular system. The axial length of the primary coil 62will usually fall in the range of 0.5 cm to 100 cm, more usually 2 cm to40 cm. Depending on the usage, the primary coil 62 may have 10-75 turnsper centimeter, preferably 10-40 turns per centimeter. All of thedimensions here are provided only as guidelines, and the invention, whenapplied to vaso-occlusive devices, should not be limited thereto. Onlydimensions that are suitable for use in occluding sites within the humanbody, however, are included in the scope of this invention as applied tovaso-occlusive devices.

Depending on the desired therapeutic effect and the shape of the site tobe treated, the primary coil 62 may later be treated or accessorized innumerous ways in order to enhance its therapeutic effect. The primarycoil 62 may be made to form various secondary shapes, often through theuse of heat treatment, that may be better suited to fill a particulartreatment site, as disclosed in U.S. Pat. Nos. 5,853,418 and 6,280,457,the entireties of which are hereby expressly incorporated herein byreference. Alternatively, the primary coil 62 may have little or noshape after introduction into the vascular space, as disclosed in U.S.Pat. No. 5,690,666, the entirety of which is hereby expresslyincorporated herein by reference. In addition, external materials may beadded to the outside of the primary coil 62 in an effort to increase itsthrombolytic properties. These alternative embodiments are disclosed inU.S. Pat. Nos. 5,226,911; 5,304,194; 5,549,624; and 5,382,259; theentireties of which are hereby expressly incorporated herein byreference, and 6,280,457, the entirety of which has previously beenincorporated by reference.

The vaso-occlusive implant 22 further includes a stretch-resistingfilament 70, which extends through the coil lumen 68 and is secured tothe primary coil 62 at two locations to prevent axial stretching of theprimary coil 62 in the event that the pusher member 18 must be withdrawnor repositioned to change the position of the vaso-occlusive implant 22.Specifically, the proximal and distal ends of the stretch-resistingfilament 70 are respectively affixed to the proximal and distal ends 64,66 of the primary coil 62. Alternatively, the stretch-resisting filament70 only extends through a portion of the lumen 68 and is attached to theprimary coil 62 at a location between the proximal and distal ends 64,66 of the primary coil 62.

The distal end of the stretch-resisting filament 70 may be secured tothe primary coil 62 by melting, gluing, or otherwise fixedly attachingthe stretch-resisting filament 70 to the primary coil 62, either at thedistal end 66 or some location between the proximal and distal ends 64,66 of the primary coil 62. In the illustrated embodiment, the distal endof the stretch-resisting filament 70 is glued or melted and reformedinto a distal cap 72, the diameter of which is larger than the innerdiameter of the primary coil 62. Alternatively, the stretch-resistingfilament 70 may be tied in a knot (not shown), which may or may not beattached to the primary coil 62. These methods of attachment aredisclosed in more detail in U.S. Pat. No. 5,582,619, the entirety ofwhich is hereby expressly incorporated herein by reference.

In a preferred embodiment, the stretch-resisting filament 70 is fibrousand desirably polymeric. Suitable polymeric materials can be eitherthermosetting or thermoplastic and can comprise a bundle of threads or asingle filament. Thermoplastics are preferred because they allowsimplification of the procedure for constructing the assembly, sincethey may be melted and formed into the distal cap 72. Simple tools, suchas soldering irons, may be used to form the distal cap 72. Thermosettingplastics would typically be held in place by an adhesive. Suitablepolymers include most biocompatible materials that may be made intofibers, including thermoplastics, e.g., polyesters such aspolyethyleneterephthalate (PET), especially Dacron; polyamides,including the Nylons; polyolefins, such as polyethylene, polypropylene,polybutylene, their mixtures, alloys, block, and random copolymers;polyglycolic acid; polylactic acid; fluoropolymers(polytetrafluoroethylene) or even silk or collagen. Thestretch-resisting polymer may be made from materials used as dissolvablesutures, for instance, polylactic acid or polyglycolic acid, toencourage cell growth in the aneurysm after their introduction. Highlypreferred is polypropylene, for instance, in the form of 10-0 and 9-0polypropylene suture material. The diameter of the polymer is typicallybetween about 0.0001 inches and about 0.01 inches.

The vaso-occlusive implant 22 further includes an anchor coil 74coaxially situated in the coil lumen 68. The anchor coil 74 ispreferably soldered or welded to the inner surface of the primary coil62. In the illustrated embodiment, the anchor coil 74 is preferably lessthan 2.6 mm long, preferably about 1.0 mm long. The anchor coil 74 has adistal hook 76 to which the stretch-resisting filament 70 is attached.The anchor coil 74 may be composed of the same material as the primarycoil 62. The vaso-occlusive implant 22 further includes a polymeric plug78 that is slipped over the distal end of the pusher member 18 and intothe proximal end 64 of the primary coil 62. The assembled joint is thenheated, so as to allow the thermoplastic of the polymeric plug 78 toflow and secure the primary coil 62 to the pusher member 18.

Referring now to FIG. 5, one embodiment of a bipolar implant assembly14(1) will now be described. The bipolar implant assembly 14(1)comprises the previously described vaso-occlusive implant 22 and apusher member 18(1). The pusher member 18(1) comprises an elongatedstiffening member 80, which includes an electrically conductive coilwire and an electrically insulative coating disposed over the core wire.The core wire of the stiffening member 80 can be composed of anysuitable electrically conductive and rigid material, such as stainlesssteel, and the coating can be composed of any suitable electricallyinsulative material, such as polyimide, polytetrafluoroethylene (PTFE),tetrafluoroethylene (TFE), polyparaxylxylene (e.g., Parylene),polyethyleneterephthalate (PET), polybutyleneterephthalate (PBT),cyanoacrylate adhesives, or other suitable insulating layer.

In the illustrated embodiment, the stiffening member 80 tapers from alarge diameter section 81 to a small diameter section 83. The core wireof the stiffening member 80 can be ground to effect this taper. In theillustrated embodiment, the diameter of the core wire in the largediameter section 81 of the stiffening member 80 is 0.004 inches, and thediameter of the core wire in the small diameter section 83 is 0.0025inches. The insulative coating may have a suitable thickness (e.g.,0.00035 inches). Notably, the large diameter section 81 of thestiffening member 80 provides the pusher member 18(1) with lateralrigidity, as well as tensile strength, whereas the small diametersection 83 of the stiffening member 80 provides the pusher member 18(1)with the desired lateral flexibility adjacent the vaso-occlusive implant22 to minimize kickback during detachment of the vaso-occlusive implant22.

A distal region of the core wire at the small diameter section 83 iseither not coated with the insulative coating or a portion of theinsulative coating is removed (e.g., using laser ablation) to expose aportion of the core wire, thereby forming the electrolytic severablejoint 20, which serves as the anode of the bipolar implant assembly18(1). Preferably, the length of the severable joint 20 is relativelyshort (e.g., 0.002 inches). As a result, the severable joint 20 has anarrow range of circumferential contact with the electrolyte, so thatthe dissolution of the core wire will be limited to a narrowcircumferential band, rather than a broad one, thereby resulting in aquicker erosion through the thickness of the core wire.

The pusher member 18(1) further comprises an electrically conductivecoil that serves as a return electrode 86 (i.e., the cathode of thebipolar implant assembly 18(1)). The return electrode coil 86 may beformed by winding a wire having a suitable diameter (such as, e.g.,0.00175 inches) around a mandrel. The return electrode coil 86 hassuitable dimensions; for example, an inner diameter of 0.006 inches (andthus, an outer diameter of 0.0095 inches) and a length of 0.75 mm. Inthe illustrated embodiment, a length of the wire forming the returnelectrode coil 86 is not wound, so as to make a straight tail 88 forcoupling to an electrical conductor, as will be described in furtherdetail below. The return electrode coil 86 circumferentially extendsaround the severable joint 20 and is spatially isolated from theseverable joint 20 via a spacer element 90 mounted to the stiffeningmember 80 at a location proximal to the severable joint 20 using asuitable adhesive. The return electrode coil 86 may be composed of asuitable electrically conductive material, such as silver or copper. Inthe illustrated embodiment, the spacer element 90 takes the form of acoil coated with an electrically insulative material, such as, e.g.,such as polyimide, PTFE, TFE, Parylene, PET, PBT, cyanoacrylateadhesives, or other suitable insulating layer. Alternatively, the spacerelement 90 may take the form of a tube composed of an electricallyinsulative material, such as, e.g., polyetheretherketone (PEEK).

Significantly, while the stiffening member 80 serves as a tensioningelement during deployment and retraction of the vaso-occlusive implant22, the return electrode coil 86 serves as a compression element, whileallowing the distal end of the pusher member 18(1) to remain laterallyflexible. Thus, when loading the vaso-occlusive implant 22 in axialcompression (such as during deployment), the return electrode coil 86can compress against a structure distal to the severable joint 20,thereby avoiding compression loading of the detachment zone, and thusreducing any possibility of kinking, fatiguing, or otherwise damagingthe severable joint 20 prior to detachment.

In the illustrated embodiment, the return electrode coil 86 is composedof silver with a thick layer of silver chloride, which results in a hightotal charge capacity per unit length of wire. This feature provides afacile solid to liquid phase electrochemical reaction that does notevolve gaseous bubbles. The electrochemical reaction occurs at a verylow bias voltage and is relatively insensitive to magnitude ofelectrical current. Thus, the return electrode coil 86 can be placedcloser to the severable joint 20 without introducing gaseous bubbles,which as discussed above, can insulate the detachment zone fromelectrolytes needed for the electrochemical reaction, thereby prolongingdetachment of the vaso-occlusive implant 22.

The electrochemical reaction at the return electrode coil 86 with theelectrolyte, such as sodium chloride, releases chlorine ions into theelectrolyte in accordance with the equation: AgCl(s)+1e⁻→Ag(s)+Cl⁻(aq),E⁰=0.22 V HSE. This electrochemical reaction requires low voltage, hasrapid charge transfer, and results in fast ion diffusion. Silverchloride has the unusual property of being minimally soluble in water,with the chloride released from the return electrode coil 86 being drawnto the severable joint 20. Notably, in the illustrated embodiment, theseverable joint 20 is composed of stainless steel (i.e., iron, chrome,and nickel). The resulting iron chloride, nickel chloride, and chromechloride hexahydrate is highly soluable in water. The electrochemicalreaction at the severable joint 20 releases iron into the electrolyte,thereby dissolving the severable joint 20 in accordance with theequations: Fe(s)−2e⁻, Fe(s)−3e⁻→Fe²⁺(s), Fe²⁺(s);Fe²⁺(s)+2Cl⁻(aq)→FeCl₂(aq).

The return electrode coil 86 can be chloridized in any suitable manner.In one embodiment, the return electrode coil 86 is composed of puresilver, which is chloridized by placing it in a saline solution whilethe windings are stretched to 50-100% open pitch. The return electrodecoil 86 is connected to a power supply, and a suitable electrode current(e.g., 0.1 mA) is conveyed between the coil 86 as an anode and a returnelectrode as a cathode for a suitable period of time (e.g., 10 minutes).The open pitch of the return electrode coil 86 will naturally close whenan outer sheath (described below) is heat shrunk over the coil 86.

The pusher member 18(1) further comprises a radiopaque marker, and inparticular a platinum marker coil 92, circumferentially extending aroundthe stiffening member 80 just proximal to the return electrode coil 86.The marker coil 92 may be formed by winding a wire having a suitablediameter (e.g., 0.002 inches) around a mandrel. The marker coil 92 hassuitable dimensions; for example, an inner diameter of 0.005 inches (andthus, an outer diameter of 0.009 inches) and a length of 3.0 mm. Themarker coil 92 may have an open pitch (e.g., 10%) to increase itslateral flexibility. The marker coil 92 is bonded to the stiffeningmember 80 using a suitable adhesive.

Prior to such bonding, the tail 88 of the return electrode coil 86 isproximally threaded through the lumen of the marker coil 92 andconnected to an electrical conductor 94 via suitable means, such assoldering or welding, or bonding using an electrically conductiveadhesive, such as a silver-filled epoxy. The electrical conductor 94 maybe a copper or silver wire that is coated with an electricallyinsulative material, such as, e.g., polyimide, to ensure electricalisolation of the electrical conductor 94 from the stiffening member 80,and thus, electrical isolation between the return electrode coil 86 andthe severable joint 20. The electrical conductor 94 has suitabledimensions, such as, e.g., a wire diameter of 0.0015 inches and a totaldiameter (including insulation) of 0.002 inches.

The pusher member 18(1) further comprises an electrically insulativesheath 96 disposed over the assembly, including the return electrodecoil 86, marker coil 92, and the stiffening member 80. The sheath 96 maybe composed of a suitable polymeric material, such as PTFE or TFE, andhave suitable dimensions (e.g., a wall thickness of 0.002 inches and aninner diameter of 0.006 inches). In the illustrated embodiment, thesheath 96 is heat shrunk over the assembly.

Significantly, the sheath 96 circumferentially surrounds both theseverable joint 20 and the return electrode coil 86. In addition toproviding the distal end of the pusher member 18(1) with an increasedcompressive strength (along with the return electrode coil 86), theexistence of the sheath 96 reduces the possibility ofpreviously-deployed vaso-occlusive devices from short-circuiting theseverable joint 20, which can prolong detachment time. In addition, thesheath 96 tends to exclude bodily fluids (e.g., blood) from the interiorof the pusher member 18(1), thereby reducing diffusion and convection ofan ideal electrolytic environment away from the detachment region whenthe implant assembly 14 is exposed to the bodily fluids. The idealelectrolytic environment can be created by introducing an idealelectrolyte, such as a sodium chloride solution (saline) into thedetachment region, for example, by soaking the distal end of the implantassembly 14 within the saline prior to introduction of the implantassembly 14 into the delivery catheter 12.

To facilitate wicking of the saline into the detachment zone, ahydrophilic coating can be applied to one or both of the severable joint20 and return electrode coil 86 as a rehydratable gel or water solublepolymer, such as polyvinyl alcohol. Preferably, the hydrophilic coatingis weakly anchored to the severable joint 20 so as not to hinderdetachment of the vaso-occlusive device 22. Thus, in spite of the sheath96 substantially isolating the detachment region from the exteriorenvironment, the hydrophilic quality of the detachment region allowsliquid to wick into the detachment zone upon soaking of the implantassembly 14(1) in the liquid. In an optional embodiment, the hydrophilicmaterial may comprise of, or contain, readily soluble salt or salts,such as sodium chloride, other metal chloride, metal chlorate, or metalsulfate. In the presence of water, these salt(s) dissolve, providing anion-rich electrolyte that accelerates electrochemical reaction anddissolution at the severable joint 20. In this optional case, theimplant assembly 14 need not be soaked in the electrolytic solution, butrather water, since the electrolytic solution is created within thedetachment region as the water makes contact with the severable joint 20and/or return electrode coil 86.

The pusher member 18(1) further comprises an electrically conductivehypotube 98 composed of a suitable electrically conductive material,such as stainless steel. The core wire in the proximal end of thestiffening member 80 is exposed and is bonded to the interior of thehypotube 98 using a suitable electrically conductive bonding material,such as, e.g., silver-filled epoxy. The distal end of the hypotube 98abuts the proximal end of the sheath 96. The hypotube 98 may havesuitable dimensions, e.g., an outer diameter of 0.012 inches, and aninner diameter of 0.006 inches. Thus, any portion of the hypotube 98forms the positive terminal 28 (shown in FIG. 1) that electricallycommunicates with the severable joint 20 via a forward electrical paththat includes the core wire of the stiffening member 80.

The pusher member 18(1) further comprises another electricallyinsulative sheath 100 disposed over a portion of the hypotube 98, and anelectrically conductive terminal coil 102, which serves as the negativeterminal 30 (shown in FIG. 1), mounted around the insulative sheath 100.The insulative sheath 100 may be composed of a suitable polymericmaterial, such as PTFE or TFE, and have suitable dimensions (e.g., awall thickness of 0.002 inches and an inner diameter of 0.006 inches).In the illustrated embodiment, the insulative sheath 100 is heat shrunkover the hypotube 98. The terminal coil 102 may be composed of amaterial, such as platinum, and is electrically coupled to the returnelectrode coil 86 via a return electrical path that includes theelectrical conductor 94 and the tail 88 of the return electrode coil 86.

To this end, the electrical conductor 94, which is connected to thereturn electrode coil 86 via the tail 88, is proximally threaded throughthe hypotube 98, and distally bent about the proximal end of thehypotube 98, so that the proximal end of the electrical conductor 94 canbe placed between the insulative sheath 100 and the terminal coil 102.Preferably, the electrical conductor 94 is disposed on the insulativesheath 100, and then the terminal coil 102 is bonded over the electricalconductor 94 and insulative sheath 100 using soldering or welding or anelectrically conductive adhesive, such as, e.g., silver-filled epoxy.

Referring now to FIG. 6, one embodiment of a monopolar implant assembly14(2) will now be described. The monopolar implant assembly 14(2)comprises the previously described vaso-occlusive implant 22 and apusher member 18(2). The pusher member 18(2) comprises an elongatedstiffening member 180 that includes an uninsulated electricallyconductive core wire. The core wire of the stiffening member 180 can becomposed of any suitable electrically conductive and rigid material,such as stainless steel. In the illustrated embodiment, the stiffeningmember 180 comprises a proximal section 185 and a distal section 187that are coupled together via a crimped bushing 189. Alternatively, theproximal section 185 and distal section 187 of the stiffening member 180can be soldered or welded together. The core wire of the distal section187 may have a uniform diameter equal to the smallest diameter of theproximal section 185.

In the illustrated embodiment, the stiffening member 180 tapers from alarge diameter section 181 to a small diameter section 183. The corewire of the stiffening member 180 can be ground to effect this taper. Inthe illustrated embodiment, the diameter of the core wire in the largediameter section 181 of the stiffening member 180 is 0.010 inches, andthe diameter of the core wire in the small diameter section 183 is0.0025 inches.

Like the previously described stiffening member 80, the large diametersection 181 of the stiffening member 180 provides the pusher member18(2) with lateral rigidity, as well as tensile strength, whereas thesmall diameter section 183 of the stiffening member 180 provides thepusher member 18(2) with the desired lateral flexibility adjacent thevaso-occlusive implant 22 to minimize kickback during detachment of thevaso-occlusive implant 22.

The formation of the electrolytic severable joint 20, which serves asthe anode of the monopolar implant assembly 14(2), can be the same asthat described above with respect to the pusher member 18(1). Anyportion of the larger diameter section 181 of the stiffening member 180can serve as the positive terminal 28 (illustrated in FIG. 2) thatelectrically communicates with the severable joint 20 via a forwardelectrical path that includes the core wire of the stiffening member180.

The pusher member 18(2) further comprises an electrically conductivecoil 186 that serves as an intermediate return electrode; that is, areturn electrode between the severable joint 20 and the ground electrode32 (shown in FIG. 2). The return electrode coil 186 may be formed bywinding a wire having a suitable diameter (such as, e.g., 0.00175inches) around a mandrel. The return electrode coil 186 has suitabledimensions; for example, an inner diameter of 0.006 inches and a lengthof 0.75 mm. The return electrode coil 186 circumferentially extendsaround the severable joint 20 and is spatially isolated from theseverable joint 20 via a spacer element 190 mounted to the stiffeningmember 180 at a location proximal to the severable joint 20 using asuitable adhesive. The return electrode coil 186 may be composed of asuitable electrically conductive material, such as silver or copper. Thespacer element 190 may take the same form and be constructed of the samematerials as the spacer element 90 described above.

Like the previously described return electrode 86, the return electrodecoil 186 serves as a compression element and may be coated with a layerof silver chloride to further prevent or reduce the generation ofgaseous bubbles. Unlike the previously described return electrode 86,the return electrode coil 186 is not electrically coupled to a terminal.Instead, as illustrated in FIG. 9, two electrochemical circuits arecreated: one between the severable joint 20 and the return electrodecoil 186, and one between the return electrode coil 186 and the groundreturn electrode 32. The large surface area of the return electrode coil186 provides an electrochemical circuit with a lower impedance returnpath to ground than the electrolyte itself. When a voltage is appliedbetween the severable joint 20 and the ground return electrode 32, thereturn electrode coil 186 will be at a voltage in between the severablejoint 20 and the ground return electrode 32, as illustrated in FIG. 9.Thus, the return electrode coil 186 shortens the diffusion distance formetal ions and provides a reducing surface that can plate these ions outof the electrolyte, thus lowering metal ion concentration at thedetachment region. This increases the rate of metal ion dissolution andreduces the magnitude of over-voltage required. This, in turn, reducesbubbling at the detachment region, thereby shortening the detachmenttime and making the detachment process more reliable.

The pusher member 18(2) further comprises a radiopaque marker, and inparticular a platinum marker coil 192, circumferentially extendingaround the stiffening member 80. The marker coil 192 may be formed bywinding a wire having a suitable diameter (e.g., 0.002 inches) around amandrel. In the illustrated embodiment, the distal end of the markercoil 192 is disposed within the proximal end of the return electrodecoil 186. To this end, the inner diameter of the marker coil 192 can be0.002 inches (and thus, an outer diameter of 0.006 inches) and a lengthof 3.0 mm. Like the previously described marker coil 92, the marker coil192 may have an open pitch (e.g., 10%) to increase its lateralflexibility, and may be bonded to the stiffening member 80 using asuitable adhesive, such as epoxy. The inner surface of the returnelectrode coil 186 may be bonded to the outer surface of the marker coil192 using a suitable adhesive, such as epoxy.

The pusher member 18(2) further comprises an electrically insulativesheath 196 disposed over the assembly, including the return electrodecoil 186, marker coil 192, and the stiffening member 180. The sheath 196may be composed of a suitable polymeric material, such as PTFE or TFE,and have suitable dimensions (e.g., a wall thickness of 0.002 inches andan inner diameter of 0.006 inches). In the illustrated embodiment, thesheath 196 is heat shrunk over the assembly.

Significantly, the sheath 196 circumferentially surrounds both theseverable joint 20 and the return electrode coil 186. Thus, like thepreviously described sheath 96 of the bipolar pusher member 18(1), thesheath 196 increases the compressive strength of the pusher member18(2), and reduces diffusion and convection of an ideal electrolyticenvironment away from the detachment region when the implant assembly14(2) is exposed to the bodily fluids. As previously described, suchideal electrolytic environment can be created by introducing the idealelectrolyte into the detachment region or introducing water into thedetachment region previously coated with salt. To facilitate wicking ofthe saline or water into the detachment zone, a hydrophilic coating canbe applied to one or both of the severable joint 20 and return electrodecoil 186 in the same manner previously described above.

Referring now to FIG. 7, another embodiment of a bipolar implantassembly 14(3) will now be described. The bipolar implant assembly 14(3)differs from the previously described bipolar implant assembly 14(1) inthat it includes an exposed detachment region. To this end, the bipolarimplant assembly 14(3) comprises the previously described vaso-occlusiveimplant 22 and a pusher member 18(3). The pusher member 18(3) comprisesan elongated stiffening member 280 that includes an electricallyconductive core wire and an electrically insulative coating disposedover the core wire. The core wire of the stiffening member 280 can becomposed of any suitable electrically conductive and rigid material,such as stainless steel, and the coating can be composed of any suitableelectrically insulative material, such as polyimide, PTFE, TFE,Parylene, PET, PBT, cyanoacrylate adhesives, or other suitableinsulating layer.

In the illustrated embodiment, the stiffening member 280 tapers from alarge diameter section 281 to a small diameter section 283. The corewire of the stiffening member 180 can be ground to effect this taper. Inthe illustrated embodiment, the diameter of the core wire in the largediameter section 281 of the stiffening member 280 is 0.004 inches, andthe diameter of the core wire in the small diameter section 283 is0.0025 inches.

Like the previously described stiffening member 80, the large diametersection 281 of the stiffening member 280 provides the pusher member18(3) with lateral rigidity, as well as tensile strength, whereas thesmall diameter section 283 of the stiffening member 280 provides thepusher member 18(3) with the desired lateral flexibility adjacent thevaso-occlusive implant 22 to minimize kickback during detachment of thevaso-occlusive implant 22. The construction of the core wire, coating,and formation of the electrolytic severable joint 20, which serves asthe anode of the bipolar implant assembly 14(3), can be the same as thatdescribed above with respect to the pusher member 18(1).

The pusher member 18(3) further comprises an electrically conductivecoil 286 that serves as a return electrode (i.e., the cathode of thebipolar implant assembly 14(3). The return electrode coil 286 may beformed by winding a wire having a suitable diameter (such as, e.g.,0.002 inches) around a mandrel. The return electrode coil 286 hassuitable dimensions; for example, an inner diameter of 0.003 inches (andthus, an outer diameter of 0.007 inches) and a length of 0.75 mm. In theillustrated embodiment, the return electrode coil 286 has an open pitch(e.g., 20%) to increase its lateral flexibility. The return electrodecoil 286 may be composed of a suitable electrically conductive material,such as silver or copper. The return electrode coil 286circumferentially extends around the stiffening member 280, and inparticular, is bonded to the stiffening member 280 at a locationproximal to the severable joint 20 using a suitable adhesive, such asepoxy. Like the previous return electrode coil 86, the return electrodecoil 286 serves as a compression element and may be coated with a layerof silver chloride to further prevent or reduce the generation ofgaseous bubbles.

The pusher member 18(3) further comprises a radiopaque marker, and inparticular a platinum marker coil 292, circumferentially extendingaround the stiffening member 280. The marker coil 292 may be formed bywinding a wire having a suitable diameter (e.g., 0.002 inches) around amandrel. In the illustrated embodiment, the inner and outer diameter ofthe marker coil 292 is preferably the same as the inner and outerdiameter of the return electrode coil 286; that is, an inner diameter of0.003 inches and an outer diameter of 0.007 inches. The length of themarker coil 292 may be 3.0 mm. Like the previously described marker coil92, the marker coil 292 may have an open pitch (e.g., 10%) to increaseits lateral flexibility, and may be bonded to the stiffening member 80using a suitable adhesive, such as epoxy.

The pusher member 18(3) further comprises an interconnecting flex coil295, the proximal end of which is circumferentially disposed around thedistal end of the marker coil 292, and the distal end of which iscircumferentially disposed around the proximal end of the returnelectrode coil 286. The flex coil 295 is composed of an electricallyconductive material, such as stainless steel, and is suitably bonded tothe marker coil 292 and return electrode coil 286 using an electricallyconductive adhesive, such as silver-filled epoxy. As such, the markercoil 292 and return electrode coil 286 are electrically coupledtogether. The flex coil 295 may be formed by winding a wire having asuitable diameter (e.g., 0.00175 inches) around a mandrel. The flex coil295 has suitable dimensions; for example, an inner diameter of 0.007inches (and thus, an outer diameter of 0.0105) and a length of 30 mm. Inthe illustrated embodiment, the flex coil 295 has a closed pitch.

The pusher member 18(3) further comprises an electrical conductor 294connected to the external surface of the marker coil 292 via suitablemeans, such as soldering or welding, or bonding using an electricallyconductive adhesive, such as silver-filled epoxy. The electricalconductor 292 may be a copper or silver wire that is coated with anelectrically insulative material, such as, e.g., polyimide, to ensureelectrically isolation of the electrical conductor 292 from thestiffening member 280, and thus, electrical isolation between the returnelectrode coil 286 and the severable joint 20. The electrical conductor292 has suitable dimensions, such as, e.g., a wire diameter of 0.0015inches and a total diameter (including insulation) of 0.002 inches.

The pusher member 18(3) further comprises an electrically insulativesheath 296 disposed over the assembly, including the proximal end of themarker coil 292, the electrical conductor 294, and the portion of thestiffening member 280 extending proximally from the marker coil 292,with the distal end of the sheath 296 abutting the proximal end of theflex coil 295. The sheath 296 may be composed of a suitable polymericmaterial, such as PTFE or TFE, and have suitable dimensions (e.g., awall thickness of 0.002 inches and an inner diameter of 0.006 inches).In the illustrated embodiment, the sheath 296 is heat shrunk over theassembly.

The pusher member 18(3) further comprises a first electricallyconductive hypotube 298 composed of a suitable electrically conductivematerial, such as stainless steel. The core wire in the proximal end ofthe stiffening member 280 is exposed and is bonded to the interior ofthe hypotube 298 using a suitable electrically conductive bondingmaterial, such as, e.g., silver-filled epoxy. The distal end of thehypotube 298 abuts the proximal end of the sheath 296. The hypotube 298may have suitable dimensions, e.g., an outer diameter of 0.012 inches,an inner diameter of 0.006 inches, and a length of 150 cm. Thus, anyportion of the hypotube 298 forms the positive terminal 28 (shown inFIG. 1) that electrically communicates with the severable joint 20 viathe forward electrical path that includes the core wire of thestiffening member 80.

The pusher member 18(3) further comprises a second electricallyconductive hypotube 299 composed of a suitable electrically conductivematerial, such as stainless steel. The proximal end of the electricalconductor 294 is exposed and is bonded to the interior of the hypotube299 using a suitable electrically conductive bonding material, such as,e.g., silver-filled epoxy. The hypotube 299 may have suitabledimensions, e.g., an outer diameter of 0.012 inches, an inner diameterof 0.006 inches, and a length of 10 mm. Thus, any portion of thehypotube 299 forms the negative terminal 30 (shown in FIG. 1) thatelectrically communicates with the return electrode coil 286 via returnelectrical path that includes the electrical conductor 294, marker coil292, and flex coil 295.

The pusher member 18(3) further comprises a reinforcing mandrel 300around which the proximal end of the first hypotube 298 and the distalend of the second hypotube 299 is bonded using a suitable adhesive, suchas epoxy. The reinforcing mandrel 300 may be a stainless steel wire thatis coated with an electrically insulative material, such as, e.g.,polyimide, to ensure electrically isolation between the first and secondhypotubes 299, 300, and thus, electrical isolation between the severablejoint 20 and the return electrode coil 286. The reinforcing mandrel 300has suitable dimensions, such as, e.g., a wire diameter of 0.004 inchesand a length of 10 mm.

Referring now to FIG. 8, another embodiment of a monopolar implantassembly 14(4) will now be described. The monopolar implant assembly14(4) differs from the previously described monopolar implant assembly14(2) in that the intermediate return electrode is configured to remainwith a vaso-occlusive implant 23 when detached from a pusher member18(4). As discussed above with respect to the monopolar pusher member18(2), the large surface area of the intermediate return electrodereduces bubbling at the detachment region.

The vaso-occlusive implant 23 is similar to the previously describedvaso-occlusive implant 22 in that it comprises the primary coil 62,stretch resisting filament 70, and distal cap (not shown). Thevaso-occlusive implant 23 differs in that it comprises an intermediatereturn electrode 386 in the form of an electrically conductive hypotubedisposed within the proximal end of the primary coil 62. In theillustrated embodiment, the proximal end of the primary coil 62 has anopen pitch (e.g., 4 of the proximal turns are open pitched) that iswound around, and mounted to, the intermediate return electrode 386 viasuitable means, such as soldering or welding, or bonding using anelectrically conductive adhesive, such as silver-filled epoxy. In analternative embodiment, the intermediate return electrode 386 may takethe form of an electrically conductive coil. The intermediate returnelectrode 386 is preferably composed of a biocompatible materialsuitable for chronic implantation. Notably, because the primary coil 62is electrically coupled to the intermediate return electrode 386, theeffective surface area of the intermediate return electrode 386 issubstantially increased to the extent that the primary coil 62, itself,is electrically conductive, thereby further minimizing the chance ofgaseous bubbling.

The pusher member 18(4) comprises an elongated stiffening member 380that includes an uninsulated electrically conductive core wire. The corewire of the stiffening member 380 can be composed of any suitableelectrically conductive and rigid material, such as stainless steel. Inthe illustrated embodiment, the stiffening member 380 tapers from alarge diameter section 381 to a small diameter section 383. The corewire of the stiffening member 380 can be ground to effect this taper. Inthe illustrated embodiment, the diameter of the core wire in the largediameter section 381 of the stiffening member 380 is 0.010 inches, andthe diameter of the core wire in the small diameter section 383 is0.0025 inches.

Like the previously described stiffening member 80, the large diametersection 381 of the stiffening member 380 provides the pusher member18(4) with lateral rigidity, as well as tensile strength, whereas thesmall diameter section 383 of the stiffening member 380 provides thepusher member 18(4) with the desired lateral flexibility adjacent thevaso-occlusive implant 22 to minimize kickback during detachment of thevaso-occlusive implant 22.

The pusher member 18(4) further comprises a radiopaque marker, and inparticular a platinum marker coil 392, circumferentially extendingaround the stiffening member 380. The marker coil 392 may be formed bywinding a wire having a suitable diameter (e.g., 0.002 inches) around amandrel. The marker coil 392 has suitable dimensions; for example, aninner diameter of 0.003 inch and a length of 3.0 mm. The marker coil 392may have an open pitch (e.g., 10%) to increase the lateral flexibilityof the marker coil 392.

The pusher member 18(4) further comprises an electrically insulated coil395 having an electrically conductive wire and an electricallyinsulative coating disposed thereon. The insulated coil 395 may beformed by winding a wire having a suitable diameter (e.g., 0.00175inches) around a mandrel. In the illustrated embodiment, the insulatedcoil 395 has an open pitch (e.g., 50%) to increase the lateralflexibility of the coil 395. The proximal windings of the insulativecoil 395, which are stripped of the insulative coating, arecircumferentially mounted around the distal end of the stiffening member380 via suitable means, such as soldering or welding, or bonding usingan electrically conductive adhesive, such as silver-filled epoxy.

The distal end 397 of the insulated coil 395 is straightened andextended through the lumen of the return electrode 386 of thevaso-occlusive device 23. A region of the straight section 397 is eithernot coated with the insulative material or a portion of the insulativematerial is removed (e.g., using laser ablation) to expose a portion ofthe wire, thereby forming the electrolytic severable joint 20. Theformation of the electrolytic severable joint 20, which serves as theanode of the monopolar implant assembly 14(4), can be the same as thatdescribed above with respect to the pusher member 18(2).

Like the previous intermediate return electrode 186, the returnelectrode 386 may be coated with a layer of silver chloride to furtherreduce or prevent the generation of gaseous bubbles. To facilitatewicking of the saline or water into the detachment zone, a hydrophiliccoating can be applied to one or both of the severable joint 20 andreturn electrode 386 in the same manner previously described above. Inan alternative embodiment, only an edge of the intermediate returnelectrode 386 is exposed to the severable joint 20, thereby improvingelectrolyte perfusion and reducing the overall diameter of the implantassembly.

As illustrated, the return electrode 386 circumferentially extendsaround the severable joint 20. The insulative coating proximal anddistal to the severable joint 20 provides a mechanical spacer thatprevents contact between the severable joint 20 and the return electrode386. Any portion of the proximal end of the stiffening member 380 canform the positive terminal 28 (shown in FIG. 2) that electricallycommunicates with the severable joint 20 via a forward electrical paththat includes the coil wire of the stiffening member 380 and the coil395.

The straight section 397 of the insulated coil 395 is threaded throughthe stretch resisting filament 70 and bent 180 degrees to form a linkwith the stretch resisting filament 70. The straight section 397 is thenwound around, and mounted to, the return electrode 386 via suitablemeans, such as soldering or welding, or bonding using an electricallyconductive adhesive, such as silver-filled epoxy. The newly formedwindings of the insulated coil 395 fit between the open pitch windingsof the primary coil 62 to minimize any increase in the outer diameter ofthe return electrode 386.

The pusher member 18(4) further comprises an electrically insulativesheath 396 disposed over the assembly, including the insulated coil 395,marker coil 392, and the stiffening member 380. The sheath 396 may becomposed of a suitable polymeric material, such as PTFE or TFE, and havesuitable dimensions (e.g., a wall thickness of 0.002 inches and an innerdiameter of 0.006 inches). In the illustrated embodiment, the sheath 396is heat shrunk over the assembly.

Although the implant assembly 14(4) has been described as a monopolarassembly, a bipolar implant assembly can be constructed by connectingthe return electrode directly to ground return through a wire attachedto the delivery catheter 12 (shown in FIGS. 1 and 2) or a wire extendingthrough the pusher member 18(4). In this case, the primary coil 62 ofthe vaso-occlusive implant 22 can be electrically insulated from thereturn electrode 386.

Referring now to FIG. 10, another embodiment of a bipolar implantassembly 14(5) will now be described. The bipolar implant assembly 14(5)differs from the previously described bipolar implant assembly 14(1) inthat it utilizes electrically conductive sheaths in the forwardelectrical path between the severable joint 20 and the positiveelectrode 28, and in the return electrical path between the returnelectrode and the negative terminal 30 (shown in FIG. 1).

The bipolar implant assembly 14(5) comprises the previously describedvaso-occlusive implant 22 and a pusher member 18(5). The pusher member18(5) comprises an elongated stiffening member 480 that includes aproximal stiffening member element 485 and a distal stiffening memberelement 487. The proximal stiffening member element 485 comprises anuninsulated core wire, and the distal stiffening member element 487comprises an insulated core wire. The core wires of the stiffeningmember elements 485, 487 can be composed of any suitable electricallyconductive and rigid material, such as stainless steel, and the coatingcan be composed of any suitable electrically insulative material, suchas polyimide, PTFE, TFE, Parylene, PET, PBT, cyanoacrylate adhesives, orother suitable insulating layer.

The distal end of the proximal stiffening member element 485 includes aforked member 489 in which the proximal end of the distal stiffeningmember element 487 is mounted. The proximal end of the core wire in thedistal stiffening member element 487 is left exposed, so that theproximal stiffening member element 485 is in electrical communicationwith the distal stiffening member element 487. An uninsulated wire iswrapped around the distal end of the proximal stiffening member element485 to form a coil 491 that firmly secures the distal stiffening memberelement 487 within the forked member 489 of the proximal stiffeningmember element 485.

In the illustrated embodiment, the proximal stiffening member element585 tapers from a large diameter section 481 to a small diameter section483. The core wire of the proximal stiffening member element 485 can beground to effect this taper. In the illustrated embodiment, the diameterof the core wire in the large diameter section 481 is 0.010 inches, andthe diameter of the core wire in the small diameter section 483 is0.0025 inches. The diameter of the core wire in the distal stiffeningmember element 487 is smaller than the core wire in the small diametersection 483 of the proximal stiffening member element 485; for example0.0015 inches. The insulative coating on the core wire of the distalstiffening member element 487 may have a suitable thickness (e.g.,0.00035 inches).

Like the previously described stiffening member 80, the large diametersection 481 of the proximal stiffening member element 485 provides thepusher member 18(4) with lateral rigidity, as well as tensile strength,whereas the small diameter section 483 of the proximal stiffening memberelement 485 and even smaller diameter distal stiffening member element487 provide the pusher member 18(5) with the desired lateral flexibilityadjacent the vaso-occlusive implant 22 to minimize kickback duringdetachment of the vaso-occlusive implant 22. The electrolytic severablejoint 20, which serves as the anode of the bipolar implant assembly14(5), is formed on the distal stiffening member element 487 in the samemanner as the severable joint 20 is formed on the core wire of thestiffening member 80 of the pusher member 18(1).

The pusher member 18(5) further comprises an electrically conductivecoil 486 that serves as a return electrode (i.e., the cathode of thebipolar implant assembly 14(5). The return electrode coil 486 may beformed by winding a wire having a suitable diameter (such as, e.g.,0.00175 inches) around a mandrel. The return electrode coil 486 hassuitable dimensions; for example, an inner diameter of 0.006 inches (andthus an outer diameter of 0.0095 inches) and a length of 0.75 mm. Thereturn electrode coil 486 may be composed of a suitable electricallyconductive material, such as silver or copper. In the illustratedembodiment, the return electrode coil 486 has an open pitch (e.g., 20%)to increase its lateral flexibility. The return electrode coil 486circumferentially extends around the severable joint 20 and is spatiallyisolated from the severable joint 20 via a spacer element 490 mounted tothe distal stiffening member element 487 at a location proximal to theseverable joint 20 using a suitable adhesive. The spacer element 490 maytake the same form and be constructed of the same materials as thespacer element 90 described above. Like the previous return electrodecoil 86, the return electrode coil 486 serves as a compression elementand may be coated with a layer of silver chloride to further prevent orreduce the generation of gaseous bubbles.

The pusher member 18(5) comprises an electrically conductive sheath 493bonded around the smaller diameter section 483 of the proximalstiffening member element 485 using suitable means, such assilver-filled epoxy or shrink tubing. In the illustrated embodiment, theelectrically conductive sheath 493 extends from the proximal end of thesmall diameter section 483 of the proximal stiffening member element 485to the distal end of the small diameter section 483 of the proximalstiffening member element 485 just proximal to the securing coil 491.The pusher member 18(5) further comprises an electrically insulativesheath 497 disposed over the proximal stiffening member element 485,electrically conductive sheath 493, and securing coil 491. The pushermember 18(5) further comprises another electrically conductive sheath498 suitably bonded around the electrically insulative sheath 497coincident with the large diameter section 481 of the proximalstiffening member element 485, using suitable means, such epoxy. Thepusher member 18(5) further comprises an electrically insulative sheath496 disposed over the assembly, including the return electrode coil 486,marker coil 492, and flex coil 495.

The electrically conductive sheaths 493, 498 may take the form of, e.g.,a mesh, braid, or coil. In the embodiment illustrated in FIG. 10, theelectrically conductive sheaths 493, 498 take the form of mesh. Whilethe core wire of the stiffening member 480 is preferably composed of amaterial that has a greater durometer than the material from which theelectrically conductive sheaths 493, 498 are composed; for example,stainless steel, the electrically conductive sheaths 493, 498 arepreferably composed of a material that is more electrically conductivethan the material from which core wire of the stiffening member 480 iscomposed; for example, silver or copper. The electrically insulativesheaths 496, 497 may be composed of a suitable polymeric material, suchas PTFE or TFE, and have suitable dimensions (e.g., a wall thickness of0.002 inches and an inner diameter of 0.006 inches).

Significantly, the sheath 496 circumferentially surrounds both theseverable joint 20 and the return electrode coil 486. Thus, like thepreviously described sheath 96 of the bipolar pusher member 18(1), thesheath 496 increases the compressive strength of the pusher member18(5), and reduces diffusion and convection of an ideal electrolyticenvironment away from the detachment region when the implant assembly14(5) is exposed to the bodily fluids. As previously described, suchideal electrolytic environment can be created by introducing the idealelectrolyte into the detachment region or introducing water into thedetachment region previously coated with salt. To facilitate wicking ofthe saline or water into the detachment zone, a hydrophilic coating canbe applied to one or both of the severable joint 20 and return electrodecoil 486 in the same manner previously described above.

The pusher member 18(5) further comprises a radiopaque marker, and inparticular a platinum marker coil 492, circumferentially extendingaround the small diameter section 483 of the proximal stiffening memberelement 485. The marker coil 492 may be formed and constructed of thesame material as the marker coil 92 described above. The pusher member18(5) further comprises a flex coil 495 circumferentially extendingaround the small diameter section 483 of the proximal stiffening memberelement 485 just proximal to the marker coil 492. The flex coil 495 iscomposed of an electrically conductive material, such as stainlesssteel. In the illustrated embodiment, the flex coil 495 has a closedpitch. The marker coil 492 and flex coil 495 preferably have the samediameter as the return coil 486.

The pusher member 18(5) further comprises an electrical conductor 494connected between the return electrode coil 486 and the otherelectrically conductive sheath 498 via suitable means, such as solderingor welding, or bonding using an electrically conductive adhesive, suchas silver-filled epoxy. The electrical conductor 492 may be a copper orsilver wire. In the illustrated embodiment, the electrical conductor 494is disposed on the outside of the electrically insulative sheath 497 toensure electrically isolation of the electrical conductor 492 from thestiffening member 480, and thus, electrical isolation between the returnelectrode coil 486 and the severable joint 20. The electrical conductor492 has suitable dimensions, such as, e.g., a wire diameter of 0.0015inches and a total diameter (including insulation) of 0.002 inches.

The pusher member 18(5) further comprises an electrically insulativesheath 496 disposed over the assembly, including the return electrodecoil 486, marker coil 492, and flex coil 495. The sheath 496 may becomposed of a suitable polymeric material, such as PTFE, and havesuitable dimensions (e.g., a wall thickness of 0.002 inches and an innerdiameter of 0.006 inches). In the illustrated embodiment, the sheath 496is heat shrunk over the assembly.

A portion of the core wire in the proximal stiffening member element485, and in the illustrated embodiment the proximal tip of the proximalstiffening member element 485, is left exposed to form the positiveterminal 28 (shown in FIG. 1) that electrically communicates with theseverable joint 20 via a forward electrical path that includes thestiffening member 480 and the electrically conductive sheath 493.Advantageously, the stiffening member 480 provides the necessarypushability for the implant assembly 14(5), while the high electricallyconductive sheath 493 significantly decreases the electrical conductancealong the portion of the forward electrical path that is coincident withthe small diameter section 483 of the proximal stiffening member element485 where the electrical conductance would otherwise decrease relativeto the large diameter section 481 of the proximal stiffening memberelement 485.

The pusher member 18(5) further comprises an electrically conductiveterminal ribbon 499, which serves as the negative terminal 30 (shown inFIG. 1), mounted around the other electrically conductive sheath 498 ata location at the proximal end of the proximal stiffening member element485. The terminal ribbon 499 may be composed of a material, such assilver or copper, and is electrically coupled to the return electrodecoil 486. Thus, the terminal ribbon 499 electrically communicates withthe return electrode coil 486 via a return electrical path that includesthe other electrically conductive sheath 498 and electrical conductor494. Advantageously, the high electrically conductive sheath 498significantly decreases the electrical conductance along the returnelectrical path compared to a case where the electrical conductor 494extends the full length between the return electrode coil 486 and theterminal ribbon 499.

Referring now to FIG. 11, still another embodiment of a bipolar implantassembly 14(6) will now be described. The bipolar implant assembly 14(6)differs from the previously described bipolar implant assembly 14(5) inthat it utilizes only one electrically conductive sheath in the returnelectrical path between the return electrode and the negative terminal30 (shown in FIG. 1). The bipolar implant assembly 14(5) comprises thepreviously described vaso-occlusive implant 22 and a pusher member18(6).

The pusher member 18(6) comprises an elongated stiffening member 580that is similar to the previously described stiffening member 480, withthe exception that substantially the entire length of the stiffeningmember 580 is insulated. Thus, the stiffening member 580 includes atapered proximal stiffening member element 585 having a large diametersection 581 and a small diameter section 583, and a distal stiffeningmember element 587. The distal end of the proximal stiffening memberelement 585 has forked member 589 in which the proximal end of thedistal core wire element 587 is mounted via a securing coil 591. Theconstruction and dimensions of the proximal stiffening member element585, distal stiffening member element 587, and securing coil 591 may bethe same as the proximal stiffening member element 485, distalstiffening member element 487, and securing coil 491 described above,with the exception that both stiffening member elements 585, 587comprise core wires coated with an electrically insulative material.

Like the previously described stiffening member 80, the large diametersection 581 of the proximal stiffening member element 585 provides thepusher member 18(6) with lateral rigidity, as well as tensile strength,whereas the small diameter section 583 of the proximal stiffening memberelement 585 and even smaller diameter distal stiffening member element587 provide the pusher member 18(6) with the desired lateral flexibilityadjacent the vaso-occlusive implant 22 to minimize kickback duringdetachment of the vaso-occlusive implant 22. The electrolytic severablejoint 20, which serves as the anode of the bipolar implant assembly14(6), is formed on the distal stiffening member element 587 in the samemanner as the severable joint 20 is formed on the stiffening member 80of the pusher member 18(1).

The pusher member 18(6) comprises an electrically conductive sheath 598suitably bonded around the proximal stiffening member element 585 usingsuitable means, such epoxy. The electrically conductive sheath 598 maytake the form of, e.g., a mesh, braid, or coil. In the illustratedembodiment, the electrically conductive sheath 598 is a coil. Theelectrically conductive sheath 598 is composed of a material that ismore electrically conductive than the material from which the stiffeningmember 580 is composed; for example, silver or copper.

The pusher member 18(6) further comprises an electrically conductivecoil 586 that serves as a return electrode (i.e., the cathode of thebipolar implant assembly 14(6)), a radiopaque marker, and in particulara platinum marker coil 592, and a flex coil 595 that circumferentiallyextend around the stiffening member 590 in the same manner as therespective return electrode coil 486, marker coil 492, and flex coil 495described above. That is, the proximal end of the return electrode coil586 is bonded around the securing coil 591, and the marker coil 592 andflex coil 595 are bonded around the electrically conductive sheath 598along the small diameter section 583 of the proximal stiffening memberelement 585. The return electrode coil 586 is spatially isolated fromthe severable joint 20 via a spacer element 590 mounted to the distalstiffening member element 587 at a location proximal to the severablejoint 20 using a suitable adhesive.

The return electrode coil 586, marker coil 592, flex coil 595, andspacer element 590 may take the same form and be constructed of the samematerials as the respective return electrode coil 486, marker coil 492,flex coil 495, and spacer element 490 described above. Like the previousreturn electrode coil 86, the return electrode coil 586 serves as acompression element and may be coated with a layer of silver chloride tofurther prevent or reduce the generation of gaseous bubbles.

The pusher member 18(6) further comprises an electrically insulativesheath 596 disposed over the assembly, including the return electrodecoil 586, marker coil 592, and flex coil 595. The sheath 596 may becomposed of the same material and have the same dimensions as the sheath496 described above. Significantly, the sheath 596 circumferentiallysurrounds both the severable joint 20 and the return electrode coil 586.Thus, like the previously described sheath 96 of the bipolar pushermember 18(1), the sheath 596 increases the compressive strength of thepusher member 18(6), and reduces diffusion and convection of an idealelectrolytic environment away from the detachment region when theimplant assembly 14(6) is exposed to the bodily fluids. As previouslydescribed, such ideal electrolytic environment can be created byintroducing the ideal electrolyte into the detachment region orintroducing water into the detachment region previously coated withsalt. To facilitate wicking of the saline or water into the detachmentzone, a hydrophilic coating can be applied to one or both of theseverable joint 20 and return electrode coil 586 in the same mannerpreviously described above.

The core wire in a portion of the proximal stiffening member element585, and in the illustrated embodiment the proximal tip of the corewire, is left exposed to form the positive terminal 28 (shown in FIG. 1)that electrically communicates with the severable joint 20 via a forwardelectrical path formed only by the stiffening member 580. Any portion ofthe electrically conductive sheath 598 may serve as the negativeterminal 30 (shown in FIG. 1). Thus, the entire electrically conductivesheath 598 forms the forward electrical path to the return electrodecoil 586. Advantageously, the high electrically conductive sheath 586significantly decreases the electrical conductance along the electricalpath to the return electrode coil 586 compared to a standard wire thatmay otherwise extend between the return electrode coil 586 and thenegative terminal 30.

Referring now to FIG. 12, yet another embodiment of a bipolar implantassembly 14(7) will now be described. The bipolar implant assembly 14(7)differs from the previously described bipolar implant assembly 14(5) inthat it utilizes coils, instead of mesh, for the electrically conductivesheaths. To this end, the bipolar implant assembly 14(7) comprises thepreviously described vaso-occlusive implant 22 and a pusher member18(7).

The pusher member 18(7) comprises an elongated stiffening member 680that is similar to the previously described stiffening member 480. Inparticular, the stiffening member 680 includes a tapered proximalstiffening member element 685 having a large diameter section 681 and asmall diameter section 683, and a distal stiffening member element 687.The distal end of the proximal stiffening member element 685 has forkedmember 689 in which the proximal end of the distal core wire element 687is mounted via a securing coil 691. The construction and dimensions ofthe proximal stiffening member element 685, distal stiffening memberelement 687, and securing coil 691 may be the same as the proximalstiffening member element 485, distal stiffening member element 487, andsecuring coil 491 described above.

Like the previously described stiffening member 80, the large diametersection 681 of the proximal stiffening member element 585 provides thepusher member 18(7) with lateral rigidity, as well as tensile strength,whereas the small diameter section 683 of the proximal stiffening memberelement 685 and even smaller diameter distal stiffening member element687 provide the pusher member 18(7) with the desired lateral flexibilityadjacent the vaso-occlusive implant 22 to minimize kickback duringdetachment of the vaso-occlusive implant 22. The electrolytic severablejoint 20, which serves as the anode of the bipolar implant assembly14(7), is formed on the distal stiffening member element 687 in the samemanner as the severable joint 20 is formed on the stiffening member 80of the pusher member 18(1).

The pusher member 18(7) comprises an electrically conductive sheath 693bonded around the smaller diameter section 683 of the proximalstiffening member element 685 using suitable means, such assilver-filled epoxy or shrink tubing. In the illustrated embodiment, theelectrically conductive sheath 693 extends from the proximal end of thesmall diameter section 683 of the proximal stiffening member element 685to the distal end of the small diameter section 683 of the proximalstiffening member element 685 just proximal to the securing coil 691.The pusher member 18(7) further comprises an electrically insulativesheath 697 disposed over the proximal stiffening member element 685,electrically conductive sheath 693, and securing coil 691. The pushermember 18(7) further comprises another electrically conductive sheath698 suitably bonded around the electrically insulative sheath 697coincident with the large diameter section 681 of the proximalstiffening member element 685, as well as a large portion of the smalldiameter section 683 of the proximal stiffening member element 685,using suitable means, such epoxy. The pusher member 18(7) furthercomprises an electrically insulative sheath 696 disposed over theassembly, including the return electrode coil 686, marker coil 692, andportion of the electrically conductive sheath 698.

The electrically conductive sheaths 693, 698 may take the form of, e.g.,a mesh, braid, or coil. In the embodiment illustrated in FIG. 12, theelectrically conductive sheaths 693, 698 take the form of coils. Theelectrically conductive sheaths 693, 698 are preferably composed of amaterial that is more electrically conductive than the material fromwhich core wire of the stiffening member 680 is composed; for example,silver or copper. The electrically insulative sheaths 696, 697 may becomposed of a suitable polymeric material, such as PTFE or TFE, and havesuitable dimensions (e.g., a wall thickness of 0.002 inches and an innerdiameter of 0.006 inches).

The pusher member 18(6) further comprises an electrically conductivecoil 686 that serves as a return electrode (i.e., the cathode of thebipolar implant assembly 14(6)), and a radiopaque marker, and inparticular a platinum marker coil 692 that circumferentially extendaround the stiffening member 690 in the same manner as the respectivereturn electrode coil 486 and marker coil 492 described above. That is,the proximal end of the return electrode coil 686 is bonded around thesecuring coil 691, and the marker coil 692 is bonded around theelectrically conductive sheath 698 along the small diameter section 683of the proximal stiffening member element 685. Notably, the electricallyconductive sheath 698 serves as a flex coil, and thus, a separate flexcoil is not needed in this embodiment.

The return electrode coil 686 is spatially isolated from the severablejoint 20 via a spacer element 690 mounted to the distal stiffeningmember element 587 at a location proximal to the severable joint 20using a suitable adhesive. The return electrode coil 686, marker coil692, and spacer element 690 may take the same form and be constructed ofthe same materials as the respective return electrode coil 486, markercoil 492, and spacer element 490 described above. Like the previousreturn electrode coil 86, the return electrode coil 686 serves as acompression element and may be coated with a layer of silver chloride tofurther prevent or reduce the generation of gaseous bubbles.

Significantly, the sheath 696 circumferentially surrounds both theseverable joint 20 and the return electrode coil 686. Thus, like thepreviously described sheath 96 of the bipolar pusher member 18(1), thesheath 696 increases the compressive strength of the pusher member18(7), and reduces diffusion and convection of an ideal electrolyticenvironment away from the detachment region when the implant assembly14(7) is exposed to the bodily fluids. As previously described, suchideal electrolytic environment can be created by introducing the idealelectrolyte into the detachment region or introducing water into thedetachment region previously coated with salt. To facilitate wicking ofthe saline or water into the detachment zone, a hydrophilic coating canbe applied to one or both of the severable joint 20 and return electrodecoil 686 in the same manner previously described above.

A core wire at a portion of the proximal stiffening member 685, and inthe illustrated embodiment the proximal tip of the core wire, is leftexposed to form the positive terminal 28 (shown in FIG. 1) thatelectrically communicates with the severable joint 20 via a forwardelectrical path formed only by the stiffening member 680. Any portion ofthe electrically conductive sheath 698 may serve as the negativeterminal 30 (shown in FIG. 1). Thus, like the previously describedelectrically conductive sheaths 593, 598, the electrically conductivesheaths 693, 698 increase the conductance of the forward electrical pathto the severable joint 20 and the return electrode path from the returnelectrode coil 686.

Having described the arrangement and function of the medical system 10,a method of its use in occluding an aneurysm 702 within a blood vessel700 will now be described with reference to FIGS. 13A-13C. Thevaso-occlusive device 23 (shown in FIG. 8) can similarly be delivered tothe aneurysm 702 in the following manner, but for the purposes ofbrevity, only delivery of the vaso-occlusive device 23 will be describedin detail.

Turning specifically to FIG. 13A, the delivery catheter 12 is steeredjust within a neck 704 of the aneurysm 702. At this point, thevaso-occlusive device 22 is in its undeployed shape, and is coupled tothe pusher member 18 via the electrolytically severable joint 20. Theimplant assembly 14 is situated within the lumen of the deliverycatheter 12, such that the vaso-occlusive device 22 resides within thedistal end 54 of the delivery catheter 12.

Turning to FIG. 13B, the pusher member 18 is then pushed in the distaldirection relative to the delivery catheter 12, causing thevaso-occlusive device 22 to extend out of the distal end 54 of thedelivery catheter 12, through the neck 704, and into the aneurysm 702.As the vaso-occlusive device 22 is pushed out of the delivery catheter12, the portion of the vaso-occlusive device 22 that is free from theconstraints of the delivery catheter 12 can assume its deployed shape.

Turning to FIG. 13C, the pusher member 18 continues to be pushed in thedistal direction relative to the delivery catheter 12 until the entirevaso-occlusive device 22 is deployed within the aneurysm 702. Thevaso-occlusive device 22 is then detached from the pusher member 18 byconveying an electrical current through the pusher member 18 toelectrolytically dissolve the severable joint 20.

In a bipolar arrangement (shown in FIG. 1), detachment of thevaso-occlusive device 22 can be accomplished by conveying electricalcurrent from the positive terminal 34 of the power supply 16 to thepositive terminal 28 of the pusher member 18, and along the forwardelectrical path within the pusher member 18 to the severable joint 20,and conveying electrical current from the return electrode on the pushermember 18, back along the return electrical path within the pushermember 18, and then from the negative terminal 30 of the pusher member18 to the negative terminal 36 of the power supply 16. Additionalvaso-occlusive devices 22 can be deployed within the aneurysm 702 asneeded by removing the pusher member 18 from the delivery catheter 12,inserting another implant assembly 14 within the lumen of the deliverycatheter 12, and repeating the steps illustrated in FIGS. 13B and 13C.

In a monopolar arrangement (shown in FIG. 2), detachment of thevaso-occlusive device 22 can be accomplished by conveying electricalcurrent from the positive terminal 34 of the power supply 16 to thepositive terminal 28 of the pusher member 18, and along the forwardelectrical path within the pusher member 18 to the severable joint 20,and conveying electrical current from the return electrode (ifavailable) on the pusher member 18, back along the return electricalpath within the patient's body, and then from the ground electrode 32(shown in FIG. 2) to the negative terminal 36 of the power supply 16.

Although particular embodiments of the present invention have been shownand described, it should be understood that the above discussion is notintended to limit the present invention to these embodiments. It will beobvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present invention. Thus, the present invention is intended to coveralternatives, modifications, and equivalents that may fall within thespirit and scope of the present invention as defined by the claims.

What is claimed is:
 1. An implant assembly, comprising: an elongatedpusher member, comprising an electrically insulative sheath having asheath lumen, an electrically insulated core wire extending through thesheath lumen, the core wire having a non-insulated electrolyticallyseverable portion located within a distal portion of the sheath lumen,and a return electrode defining a return electrode lumen and having aterminal portion disposed within the distal portion of the sheath lumen,wherein the sheath, the core wire, and the return electrode are fixablyattached to one another, wherein the return electrode extendscircumferentially around the severable portion; and an implantabledevice attached to the core wire distal of the severable portion,wherein the sheath has an open distal end in communication with thesheath lumen such that, when the distal end of the assembly is implantedin a blood vessel, blood enters the sheath lumen through the open distalend and forms an electrical pathway between the electrolyticallyseverable portion and the return electrode.
 2. The implant assembly ofclaim 1, wherein the core wire extends through the return electrodelumen.
 3. The implant assembly of claim 2, where the severable portionis disposed in the return electrode lumen.
 4. The implant assembly ofclaim 1, wherein the implantable device comprises a vaso-occlusivedevice.
 5. The implant assembly of claim 1, wherein at least one of theseverable portion and the return electrode has a hydrophilic coating. 6.The implant assembly of claim 1, wherein the return electrode is a coilhaving a coil lumen, and wherein the core wire passes through the coillumen.
 7. The implant assembly of claim 6, where the severable portionis disposed in the coil lumen.
 8. The implant assembly of claim 1,further comprising an electrically insulative spacer fixably attached tothe core wire, the spacer preventing contact between the core wire andthe return electrode.
 9. The implant assembly of claim 1, wherein theinsulative sheath is composed of a polymeric material.